Status:
COMPLETED
Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder
Lead Sponsor:
Hawler Medical University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of this study is to test if combining the antidepressant Citalopram with Pentoxifylline (PTX), a medicine with anti-inflammatory and phosphodiesterase inhibitory properties, enhanced antidepre...
Detailed Description
According to mounting evidence, inflammation and phosphodiesterase (PDE) pathways may play a role in the pathogenesis of psychiatric diseases such as MDD. PTX is a phosphodiesterase inhibitor and has ...
Eligibility Criteria
Inclusion
- Provide written, voluntary informed consent prior to study enrollment.
- Male or female between the ages of 21 to 65.
- Patient must be diagnosed with a moderate to a severe depressive episode, as determined by the MADRS score \>21.
- Prior to taking part in the trial, all patients were requested to abstain from all psychotropic and anti-inflammatory medications for at least four weeks.
Exclusion
- Current psychotic symptoms or perceptual problems of any kind, at the discretion of the investigator
- The presence of a contraindication to PTX, such as a drug allergy or xanthine derivative allergy
- The presence of cardiovascular diseases, including high blood pressure, a recent myocardial infarction, cardiac arrhythmia, coronary artery disease, or a coagulation disorder
- Renal impairment, defined as creatinine clearance less than 80ml/min
- Patients who have previously received electroconvulsive therapy (ECT)
- Patients who have inflammatory disorders
- Patients with a concurrent active medical condition
- Patients with a history of seizures
- Patients who are pregnant or nursing females.
- Patients with bipolar I or bipolar II disorder
- Patients with personality disorders
- Patients with eating disorders
- Patients with substance dependence or abuse
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05271084
Start Date
November 10 2021
End Date
June 8 2022
Last Update
September 7 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hawler Psychiatric Hospital and Private Clinic
Erbil, Iraq, 44001